Pfizer Tower
Seoul, 04631, South Korea
Location status: Recruiting
NCT Number: NCT05391061
The purpose of this non-interventional study is to learn about the safety and effectivness of Cibinqo Tablet for the possible treatment of atopic dermatitis (AD).
AD is a long-lasting itchy red rash, caused by a skin reaction.
This study is seeking participants who:
1. Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo 2. Have evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s) or legal guardian, have been informed of all important details of the study Investigators will collect and record the information on each participant's experiences with Cibinqo. This study medicine is a tablet which is taken by mouth. Participants will be observed for about a year. During this time, we will study the experiences of people receiving the study medicine to help us decide if the study medicine is safe and effective.
Interested in participating?
Request Info12 year and older
All sexes
Observational
Seoul, 04631, South Korea
Location status: Recruiting
This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea.
The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea.
The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.
About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study.
Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.
There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
This study is seeking participants who should meet the usual prescribing criteria for Cibinqo® Tablets as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.
Inclusion criteria
Exclusion criteria
Tablets
Other names: Cibinqo
Time frame: Up to 52 weeks from the time of first treatment
Time frame: up to 52 weeks from the time of first treatment
Time frame: up to 52 weeks from the time of first treatment
Time frame: up to 52 weeks from the time of first treatment
Time frame: up to 52 weeks from the time of first treatment
Time frame: up to 52 weeks from the time of first treatment
Time frame: up to 52 weeks from the time of first treatment
Time frame: At 12 weeks, and 52 weeks after the first treatment
Time frame: At week 12 and 52 weeks after the first treatment
Time frame: At week 12 and 52 weeks after the first treatment
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
Post Marketing Surveillance (PMS) Study for Cibinqo Tablet (Abrocitinib) in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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